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Hamida Pharma Poland Sp.Z O.O.

⚠️ High Risk

FEI: 3005231701 • Konstancin-Jeziorna, Mazowieckie • POLAND

FEI

FEI Number

3005231701

📍

Location

Konstancin-Jeziorna, Mazowieckie

🇵🇱

Country

POLAND
🏢

Address

Kr Marysienki 90, , Konstancin-Jeziorna, Mazowieckie, Poland

High Risk

FDA Import Risk Assessment

59.5
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

19
Total Refusals
1
Unique Violations
9/16/2007
Latest Refusal
8/8/2005
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
48.2×30%
Recency
0.0×20%
Frequency
90.2×10%
How is this score calculated?

Proprietary Algorithm

  • 40% Violation Severity — AI-assessed (1-10)
  • 30% Refusal Volume — Logarithmic scale
  • 20% Recency — Decays over 5 years
  • 10% Frequency — Refusals per year

© ImportRefusal.com Original Analysis

Violation Summary

7519×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

Refusal History

DateProductViolationsDivision
9/16/2007
54FCR99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
9/16/2007
54FCR99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
9/16/2007
54FCR99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
9/16/2007
54FCE99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
9/16/2007
54FCR99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
9/16/2007
54FCE99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
9/16/2007
54FCR99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
9/16/2007
54FCR99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
9/16/2007
54FCR99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
9/16/2007
54FCR99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
9/16/2007
54FCR99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
9/16/2007
54FCR99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
9/16/2007
54FCE99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
9/16/2007
54FCE99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
9/16/2007
54FCR99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
9/16/2007
54FCE99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
9/16/2007
54FCE99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
9/16/2007
54FCE99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
8/8/2005
66VAY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Hamida Pharma Poland Sp.Z O.O.'s FDA import refusal history?

Hamida Pharma Poland Sp.Z O.O. (FEI: 3005231701) has 19 FDA import refusal record(s) in our database, spanning from 8/8/2005 to 9/16/2007.

What is an FEI number?

FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Hamida Pharma Poland Sp.Z O.O.'s FEI number is 3005231701.

What types of violations has Hamida Pharma Poland Sp.Z O.O. received?

Hamida Pharma Poland Sp.Z O.O. has been cited for 1 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.

Where does this information about Hamida Pharma Poland Sp.Z O.O. come from?

All FDA import refusal data for Hamida Pharma Poland Sp.Z O.O. is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.

Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.